Methadone Hydrochloride Tablet
NDC Package 64850-604-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Methadone Hydrochloride tablets is uSP are indicated for the:  1. This formulation utilizes a tablet delivery system. Marketed by Elite Laboratories, Inc., this product is identified by NDC 64850-604 and is authorized under FDA application ANDA210484.

Identification & Billing

NDC Package Code
64850-604-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
64850-604
11-Digit Billing Format
64850060401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methadone Hydrochloride
Non-Proprietary Name
Methadone Hydrochloride
Substance Name
Methadone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHADONE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Methadone Hydrochloride Tablets, USP are indicated for the:  1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.1)], reserve Methadone Hydrochloride Tablets, USP for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Tablets, USP are not indicated as an as-needed (prn) analgesic.2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.Limitations of UseMethadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Elite Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210484
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-06-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64850-604-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Methadone Hydrochloride, a human prescription drug labeled by Elite Laboratories, Inc.. This tablet is formulated for oral use and contains methadone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Elite Laboratories, Inc. on August 06, 2018. The current certification is valid through December 31, 2026.

How is this Elite Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64850060401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
64850-604-01
11-Digit CMS (5-4-2)
64850-0604-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.